This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan.

Primary Objective:

To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents

Secondary Objective:

To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.

Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]

Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.

Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]

Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.

Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL.

Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]

Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL® [ Time Frame: Day 0 pre-vaccination ] [ Designated as safety issue: No ]

Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.

Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and day 28 post-vaccination ] [ Designated as safety issue: No ]

Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.

Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and day 28 post-vaccination ] [ Designated as safety issue: No ]

Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.

Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ] [ Designated as safety issue: No ]

Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ] [ Designated as safety issue: No ]

Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]

Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.

Eligibility

Ages Eligible for Study:

11 Years to 12 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Aged 11 or 12 years on the day of inclusion

Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively

Able to attend all scheduled visits and to comply with all trial procedures

For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.

Exclusion Criteria:

Any conditions or diseases which, in the opinion of the investigator

would pose a health risk to the subject

or might interfere with the ability to participate fully in the study

or might interfere with evaluation of the vaccine

or would otherwise make participation inappropriate according to the investigator's clinical judgment

History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically

Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine

Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis

Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion

Planned participation in another clinical trial during the present trial period

Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response

Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine

Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689324